S-6437 (Sustained release cephalexin granule for pediatric use) was studied with the following results:
1) Following the single oral administration of 25mg/kg of S-6437 in 6 children of 4-6 years old, the following blood levels (average) of cephalexin were obtained: 3.1μg/ml in one hour after the administration, 8.6 Eg/ml in 2 hours, 8.7 in 4. hours, 7.2 in 6 hours, 4.0 in 8 hours and 1.2 in 12 hours.
Effective blood levels of cephalexin by S-6437 were maintained for longer period of time than those by regular cephalexine dry syrup.
In 4 of 6 children receiving S-6437, cephalexin was scarcely detected in their blood in 12 hours after the administration. From this, it is not considered that S-6437 is accumulated in body.
2) S-6437 was administered to 38 patients including: 7 with pneumonia, 7 with acute bronchitis, 1 with suppurative lymphadenitis, 4 with acute pharyngitis, 15 with acute tonsillitis and 4 with acute urinary tract infections. Out of the 35 cases, 31 (88.6%) responded to S-6437, and 3 cases could not be evaluated.
3) Transient diarrhea in 2 patients, rash in 1 and elevation of serum GOT, GPT and LDH in 1 were observed. However, these side effects were improved by discontinuation of S-6437.

View full abstract

We reviewed and discussed comparative double blind clinical studies of sustained release cephalexin (S-6437) with regular cephalexin conducted by Dr. Fujii and G.P.'s group consisting of pediatricians in pediatric patients with acute upper respiratory tract infections who visited their clinics within 24 hours after fever appeared. The following is the summary of our findings on the studies:
(1) It was found that total evaluation of the drugs by the investigators in the studies was done based upon many clinical examinations and about 64% of the total evaluation was covered by 15 examinations such as body temperature, subjective and objective symptoms, and the amount of food intake on the initial treatment day, the degree of improvement of symptoms (except objective symptoms) on the 2nd treatment day, the degree of improvement of symptoms on the 3rd treatment day, and recovery days.
The total evaluation in the studies was performed based mainly upon symptoms (e.g. body temperature, objective symptoms and amount of food intake) which can objectively be observed. Especially, antipyretic time, objective symptoms and ithe degree of improvement of the symptoms on the 3rd treatment day were taken as important factors for the drug evaluation.
(2) The degree of subjective symptoms on the initial treatment day, the degree of improvement of the symptoms on the 2nd and the 3rd treatment days, and recovery days of the symptoms were highly relative to body temperature.
(3) The patients in the studies showed notable improvement or recovery within 48 hours after the initiation of the treatment.
(4) From the above finding, the evaluation of the drugs by the investigators in the studies was considered to be made based upon objective evidences.
(5) Also, it was considered to be important to examine body temperature, objective symptoms and amount of food intake at short intervals in early stage of the disease for the drug evaluation in pediatric patients with acute upper respiratory tract infections, though many examinations will be required for the evaluation.

View full abstract

1. Minocycline (MNC)(10mg/kg) and gentamicin (GM)(5mg/kg), in combination with pre- or post-treatment, were intravenously injected to the rat or rabbit to investigate their pharmacokinetics.
2. The antibiotics in the samples were separated by the paper electrophoretic technique and their concentrations were determined by the cup thin-layer plate method using Bacillus subtilis as the test organism.
3. In the rat, the biological half life of MNC was shortened when combined with GM, and its initial level was elevated. On the other hand, the biologital half life of GM was prolonged, and its initial level was decreased. Similar results were observed irr the rabbit.
4. The urinary excretion rate of MNC in the rat was increased when combined with GM, while that of GM were decreased with MNC.
5. The biliary excretion rate of MNC in the rabbit was increased when combined with GM.
6. The binding rate of MNC to the serum proteins was apparently decreased when it was administered in combination with GM.

View full abstract

This paper reviews a clinical background of the patients from whom Ps. maltophilia was isolated at the Juntendo University Hospital during 7-month period from July 1976 until January 1977. In addition, data are presentated concerning the antimicrobial susceptibility of this organism.
1) Eighty four strains of Ps. maltophitia from 58 patients were isolated from various clinical specimens. Approximately 50% of the isolates was recovered from sputum, 17% from urine (105/ml) and 6% from pus and bile either. There was no isolation from blood or spinal fluid.
2) In a retrospective review of the 21 patients involved, most of the patients were in very ill and suffered from chronic debilitated diseases. Some had major surgery, and all but 2 patients received antimicrobial treatment prior to the isolation of the organism. Ps. maltophilia is an opportunistic pathogen but it is not always etiologically significant when found in clinical specimen.
3) From the results of in vitro antimicrobial activities of 15 chemotherapeutic agents by using agar dilution method, this species was found to show a considerable strain variation in its susceptivility to antibiotics. All strains studied were susceptible to minocycline and doxycycline, and about 50% of the strains to colistin. Most strains were resistant to other antibiotics, including ampicillin, sulbenicillin, carbenicillin, cefazolin, kanamycin, gentarnicin, dibekacin, amikacin, tetracycline, chlorampheniool, lincomycin and clindamycin.

View full abstract

[in Japanese]

View full abstract

[in Japanese]

View full abstract